Menopausal HT for Women Living With HIV (HoT)

NCT06856174 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: ACTG A5424UM1AI068636
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief Summary

Women living with HIV have been shown to experience more frequent and severe hot flashes and night sweats (collectively known as vasomotor symptoms) as compared to women living without HIV. This correlates with disturbed sleep, increased depressive symptoms, increased anxiety, worse mental function, interference with activities of daily living including work, and worse overall quality of life. Hormone therapy is considered to be the most effective therapy for hot flashes and night sweats and the most appropriate choice to prevent bone loss at the time of menopause for women without HIV. However, the usefulness of hormone therapy has not been specifically studied in women living with HIV. This trial is being done to see if:

• There is evidence to support the use of hormone therapy (estradiol with or without progesterone) for the treatment of hot flashes and night sweats in women living with HIV
• Hormone therapy improves mental function, mood, sleep, quality of life, bone health, heart health, and inflammation in women living with HIV
• Hormone therapy is safe and tolerable for women living with HIV

Conditions

HIV Infection; Menopause

Outcome Measures

Primary Outcomes (1)

• Change in vasomotor symptoms (VMS) frequency

  Change in self-reported mean VMS frequency per day from 5-week observation phase prior to randomization to the one-week period prior to week 12 visit following.

  From 5 weeks prior to randomization to Week 12

Secondary Outcomes (16)

• Change in vasomotor symptom (VMS) severity

  From 5 weeks prior to randomization to week 12

• Change in sleep

  From randomization to week 12

• Change in insomnia

  From randomization to week 12

• Change in quality of life

  From randomization to week 12

• Percentage of participants with adverse events associated with hormone therapy

  From randomization to week 12

Study Arms (2)

Arm A: Hormone Therapy

ACTIVE COMPARATOR

PARTICIPANTS WITH INTACT UTERUS: Transdermal estradiol gel plus oral micronized progesterone daily for 12 weeks. PARTICIPANTS WITHOUT A UTERUS: Transdermal estradiol gel daily for 12 weeks.

Drug: Transdermal estradiol gel; Drug: Micronized Progesterone

Arm B: Hormone Therapy Placebo

PLACEBO COMPARATOR

PARTICIPANTS WITH INTACT UTERUS: Transdermal placebo gel plus oral encapsulated placebo pill daily for 12 weeks. PARTICIPANTS WITHOUT A UTERUS: Transdermal placebo gel alone daily for 12 weeks.

Drug: Placebo for estradiol gel; Drug: Placebo for micronized progesterone

Interventions

Transdermal estradiol gel DRUG

All participants: Estradiol gel 0.1%, 0.75 grams (corresponding to estradiol 0.75 mg) applied to the skin of the upper thigh once daily for 12 weeks.

Arm A: Hormone Therapy

Micronized Progesterone DRUG

Participants with intact uterus: Encapsulated micronized progesterone 100 mg orally once daily for 12 weeks.

Arm A: Hormone Therapy

Placebo for estradiol gel DRUG

All participants: Placebo for estradiol gel 0.1%, 0.75 grams applied to the skin of the upper thigh once daily for 12 weeks.

Arm B: Hormone Therapy Placebo

Placebo for micronized progesterone DRUG

• Participants with intact uterus: Encapsulated placebo for micronized progesterone 100 mg orally once daily for 12 weeks.

Arm B: Hormone Therapy Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

* Living with HIV * Assigned female sex at birth * Between the ages of 40 and 60 years * In the late menopausal transition (perimenopause) or early postmenopause * Experiencing hot flashes and/or night sweats * Willing and able to complete a daily diary * Does not have medical condition that would contraindicate hormone therapy * Not taking medications to treat hot flashes * Not taking medications that cannot be combined with hormone therapy * Receiving antiretrovirals (HIV medication) for more than 1 year * Not pregnant and willing and able to use at least non-hormonal birth control to prevent pregnancy * Willing and able to provide informed consent after discussion with the research staff

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• National Institute on Aging (NIA): collaborator
• Exeltis: collaborator
• Xiromed LLC: collaborator

MeSH Terms

Conditions

HIV Infections

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Central Study Contacts

ACTG ClinicalTrials.gov Coordinator

CONTACT

301-628-3348; ACTGCT.gov@dlhcorp.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 19, 2025
• First Posted: March 4, 2025
• Study Start: January 19, 2026
• Primary Completion (Estimated): September 20, 2027
• Study Completion (Estimated): September 20, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months following publication and available throughout period of funding of the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) by NIH.
• Access Criteria: * With whom? Researchers who provide a methodologically sound proposal for use of the data that is approved by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG). * For what types of analyses? To achieve aims in the proposal approved by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG). * By what mechanism will data be made available? Researchers may submit a request for access to data using the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Group (ACTG) "Data Request" form at: https://actgnetwork.org/about-actg/templates-and-forms. Researchers of approved proposals will need to sign an Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) Data Use Agreement before receiving the data.